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The Smith & Nephew ANTHEM PS Total Knee System is intended for total knee arthroplasty.

Indications for Use:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

The subject ANTHEM PS Total Knee System is a posterior stabilized implant design that includes cobalt chromium (ASTM F75) femoral components and titanium (ASTM F1472) tibia baseplate components that are intended to be used with existing GENESIS II components to complete the total knee construct. The femoral components are based on the LEGION Narrow PS (K112941) and GENESIS II PS (K951987) designs, and are available in two categories: ANTHEM Standard (Sizes: 3-8; left and right options) and ANTHEM Narrow (Sizes 1-6; left and right options). The ANTHEM Tibia Baseplates are leveraged from the GENESIS II Tibia Baseplate (K951987) design, with a modification to the stem, and provided in sizes 1-8 with left and right options. All of the implants are gamma sterilized single-use prescription devices intended to be used under the guidance of a physician at a healthcare facility.

This document is a 510(k) Premarket Notification for a medical device (ANTHEM PS Total Knee System) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical study would for an AI/software device.

Therefore, the requested information elements related to AI device performance evaluation, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not present in this document.

However, I can provide the available information regarding the "study" that proves the device meets requirements, which in this context refers to preclinical bench testing to establish substantial equivalence.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria with specific quantitative performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices through biomechanical testing. The "acceptance criteria" here is implicitly that the device performs comparably to the predicate devices in the described tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not explicitly stated in terms of number of devices tested, but the testing was "non-clinical bench (mechanical) testing" done on "the proposed femoral and tibial components." This typically involves a set number of test samples for each device variant and test type, as per ASTM standards, but specific numbers are not detailed here.
• Data Provenance: The testing was conducted as part of the regulatory submission process for Smith & Nephew, Inc., located in Memphis, TN, USA. This is preclinical (bench) data, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is a mechanical device, and "ground truth" for mechanical testing is established by the test setup, calibration, and adherence to ASTM standards by engineers and technicians, not clinical experts for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a mechanical device; there's no "adjudication" in the clinical sense for determining ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document pertains to a total knee system, not an AI or software device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This document pertains to a total knee system, not an AI or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this mechanical device, the "ground truth" used for testing aligns with established ASTM (American Society for Testing and Materials) standards for orthopaedic implants. These standards define the methodology and expected performance characteristics for evaluating factors like contact area and constraint. The "truth" is whether the device's mechanical performance conforms to these scientific/engineering benchmarks and is comparable to predicate devices.

8. The sample size for the training set:

Not applicable. This document pertains to a mechanical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set is involved for this type of device submission.

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